Enhancing Prevention Capacity With Developmental Assets and Getting to Outcomes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Enhancing Prevention Capacity With Developmental Assets and Getting to Outcomes (NCT00780338), a randomized phase 2 study. The primary outcome is Prevention Capacity-GTO Efficacy (Intent to Treat).

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group Phase 2 study with no masking. It lists an enrollment of 376 and identifies twelve community-based prevention coalitions in Maine as participating. Six coalitions, determined at random according to the brief summary, were to receive the Assets Getting To Outcomes intervention. The record describes two cohorts: Cohort 1 receives the intervention first, while Cohort 2 receives it second, after Cohort 1 is done receiving it. The full details of the assignment process and the control condition are not reported in the registry record.

AGTO combines Developmental Assets and Getting To Outcomes. The former is described as supporting community mobilization and collaboration to promote positive youth development; the latter is intended to enhance community capacity to complete prevention tasks, including evaluation. The brief summary describes manuals, training, and on-site technical assistance. It also notes that assistance is adapted to the needs and priorities of participants and their settings, though the intervention description is truncated in the registry record.

The study is listed as completed, with a start date of 2008-06 and primary completion date of 2013-01. The record identifies substance abuse as the condition. It describes a project intended to assess intervention delivery and use, effects on coalition members’ prevention capacity and prevention performance, and whether increased capacity improves alcohol and drug outcomes among youth. Those aims are broader than the designated primary outcome, which measures practitioner efficacy. The record does not report the detailed timing of all assessments beyond the primary outcome’s baseline, mid-point (1 year), and posttest (2 years) schedule.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Baseline to Mid (1 Year)

Mid to Post (1 Year; 2 Years in Total)

Analysis population for the primary outcome, as defined in the registry: Despite drop outs, all the data was used.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Prevention Capacity-GTO Efficacy (Intent to Treat), measured over Baseline, mid-point (1 year), posttest (2 years).

The primary outcome is Prevention Capacity-GTO Efficacy (Intent to Treat). It measures practitioners’ reported efficacy for carrying out activities associated with the AGTO 10 steps. The registry says the measure is assessed in the Coalition Survey and is expressed as a percentage of the highest possible score. It is based on 10 items, each using a three-point response scale ranging from needing a great deal of help to carry out a task to being able to carry it out without any help. The item sum is transformed to a 1-100% scale.

The registry explains that a percentage-point change corresponds to a .02 change on the original 1-3 scale, and that a 50-percentage-point change corresponds to a one-point change on that scale. These details help clarify what the score represents; they are not observed treatment effects. The intended assessment times are baseline, mid-point (1 year), and posttest (2 years).

As a self-reported efficacy measure, the endpoint addresses practitioners’ perceived ability, rather than directly measuring youth substance use or the quality of prevention services. The registry also lists prevention performance and other prevention-capacity outcomes as secondary outcomes. The numerical primary-outcome results are not reported in the registry record, so its observed direction and magnitude cannot be described.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is continuous and summarized using a mean and standard deviation. General: A continuous measure can take values across a scale rather than being limited to categories. The mean conveys the average level, while the standard deviation describes how dispersed individual scores are around that average. A standard deviation is not the uncertainty in the mean or in a treatment contrast; those require an inferential estimate such as a standard error or confidence interval. The registry record does not report numerical means or standard deviations for the primary outcome.

What does the score represent?

The efficacy scale combines responses to 10 questions about tasks associated with the AGTO steps. Each response uses a three-point scale, with higher responses corresponding to greater reported independence in carrying out the task. The sum is transformed to a 1-100% scale. This transformation places the score on a percentage-of-the-highest-possible-score scale; it does not mean that the score is a percentage of practitioners who can perform a task. The registry explains how percentage-point changes map to the original scale, but does not report an observed change.

What does intent to treat mean in this record?

The registry labels the primary outcome analysis intent to treat. In general, an intent-to-treat approach aims to retain participants in the groups to which they were assigned, regardless of intervention participation after assignment. The registry’s population description says that all the data was used despite dropouts. It does not state how missing assessments were treated, whether all assigned participants contributed outcome data, or the exact model used. Those details are not reported in the registry record, so a more specific account of the analysis cannot be inferred.

How should the assessment schedule be understood?

The stated times are baseline, mid-point (1 year), and posttest (2 years). General: Repeated measurements can describe both the level of an outcome and how it changes across time. Comparing groups over time may require an analysis that accounts for the relationship among measurements from the same participant. The registry does not identify the statistical model, the contrast used to summarize change, or whether the primary comparison focused on a particular time point or a pattern across time. Those choices affect the estimate and its uncertainty and are not reported in the registry record.

Why does allocation matter?

Random allocation is intended to make assigned groups comparable, on average, with respect to factors present before assignment. It does not guarantee that the groups will be identical, and it does not remove the need to report outcome data and the analysis. This study is listed as randomized and parallel, with no masking. General: In an unmasked study, participants and study personnel know the assigned condition. For a survey-based self-report outcome, awareness of assignment can be relevant when interpreting responses. The record does not report procedures intended to address that possibility.

What does the sample-size illustration mean?

The registry describes sample-size planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The illustrations vary the effect to detect as a stated fraction of the observed effect; for non-time-to-event outcomes, they are expressed as participants per arm for 80% or 90% power. The record does not report the resulting illustration values in the registry record for this analysis. General: Such calculations are planning illustrations, not observed power, and do not tell readers the precision of the trial’s actual estimate. They are also not the trial’s own design justification.

General: Over-dispersion occurs when variation in the data is greater than a statistical model assumes. If ignored, standard errors and tests can be misleading. This is a general consideration for selecting models, not a reported issue or method in this study. The registry record does not report a model, an over-dispersion assessment, or a procedure for handling it.

Finally, the registry lists 12 outcome measures and 10 analyses. These counts indicate that the record covers multiple outcomes and analyses, but do not establish which comparisons were prespecified or how inference was adjusted. The primary outcome itself has several categories or time points and is not reduced in the record to one comparison. The analysis plan and any adjustments for multiple comparisons are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 12 outcome measures and 10 analyses, including several prevention-capacity and prevention-performance outcomes. Multiple outcomes or comparisons can create a multiplicity concern: when many hypotheses are tested, the chance of at least one apparently unusual result can increase if results are interpreted without accounting for the number of tests. General: Methods such as defining a primary comparison in advance or adjusting inference across a family of tests can help address this issue. The registry record does not report whether, or how, multiplicity was handled.

The primary outcome is specified at baseline, mid-point (1 year), and posttest (2 years). The registry notes that it has several categories or time points and is not reduced to one comparison. It does not identify a single primary time-point contrast, a repeated-measures model, or a hierarchy for interpreting the outcome times. The statistical plan for those choices is not reported in the registry record.

The primary outcome carries an intent-to-treat label, and its population description says all the data was used despite dropouts. The record does not explain the extent or pattern of missing outcome data, how missing values were handled, or whether sensitivity analyses were performed. General: Missingness can affect interpretation when the probability of a measurement being unavailable relates to the outcome or to assigned group. The appropriate analysis depends on the data and assumptions; no specific missing-data method should be attributed to this trial without a registry description.

The record also does not state the detailed analysis populations for secondary outcomes, or whether interim analyses were planned or conducted. These aspects are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The safety record lists AGTO and Control groups. For serious adverse events, it reports 174 at risk and 0 affected in AGTO, and 202 at risk and 0 affected in Control. For other adverse events, it reports 174 at risk and 0 affected in AGTO, and 202 at risk and 0 affected in Control. These are the registry’s recorded counts; they do not supply details about event types or the period over which events were collected.

The record lists no top serious adverse-event terms. Death counts are not reported in the registry record; a blank or unavailable death entry should not be read as a reported zero. Likewise, zero affected in these entries means no events are recorded in those categories in this registry summary. It does not establish that no event occurred outside the recorded categories, observation period, or reporting process.

General: Safety counts are most interpretable when the event definition, follow-up period, ascertainment method, and population at risk are clear. The registry entries do not provide those additional details. These figures should therefore be read as a limited registry summary, not as a complete account of safety monitoring or as a comparison demonstrating absence of risk.

12. What the Result Does, and Does Not, Mean

The registry record establishes the study’s stated question and design: a randomized, parallel-group evaluation of Assets Getting To Outcomes, with practitioner GTO efficacy designated as the primary outcome. It also describes the score, its intended measurement times, and the broad aims of the project. It does not provide numerical outcome results for the primary or secondary outcomes. Therefore, it cannot show from the posted record whether AGTO was associated with a higher, lower, or similar efficacy score than control, or how precise any difference may have been.

The endpoint captures practitioners’ reported efficacy for carrying out prevention tasks. It is not a direct measure of youth alcohol or drug outcomes, and it is not itself a measure of prevention performance. The project’s broader aims include those topics, but the record does not report their numerical findings. Conclusions about one measure should not be extended to other outcomes that it does not measure.

General: Statistical significance and practical importance are different questions. A statistical test concerns compatibility between data and a specified model or null hypothesis; practical importance concerns whether an estimated difference matters in context. Both require interpretable outcome estimates and appropriate uncertainty information. Those results are not reported in the registry record, so neither question can be evaluated for the primary comparison.

The registry’s description of randomized allocation and the intent-to-treat label provides useful context, but neither substitutes for reporting the analysis, missing-data handling, group estimates, and uncertainty. Similarly, the enrollment figure is not a treatment-effect estimate and does not by itself establish precision. The appropriate conclusion is limited: the registry describes a completed trial and a primary measure, while leaving the primary result and its statistical uncertainty unreported.

13. Why This Trial Matters Statistically

This study is statistically notable for evaluating a community-based prevention approach through a measure of practitioners’ capacity, rather than defining its primary outcome as youth substance use. The registry places practitioner efficacy within a wider theory of prevention work: coalitions receive support intended to strengthen community mobilization and the capacity to carry out prevention tasks. That makes the distinction between a capacity measure and a downstream youth outcome central to interpreting what the primary endpoint can answer.

The record also describes randomized assignment at the coalition level, with two cohorts receiving the intervention at different stages. This setting highlights the need for a clear account of the assignment and analysis unit when interpreting group comparisons. Although the registry states that six coalitions were randomly determined to receive the intervention, it does not report detailed statistical methods for accounting for the coalition structure or repeated outcome assessments. Such methods are not reported in the registry record and should not be assumed.

The primary outcome is measured at multiple times and summarized as a continuous score. This creates important reporting needs: readers need the group results, the comparison across time, and uncertainty around that comparison. The registry identifies these measurement features but does not report the numerical results. Consequently, the record is useful for understanding the intended question and measure, but it does not permit an assessment of the observed effect or its precision.

More broadly, this trial illustrates why intervention-process questions, practitioner-capacity outcomes, prevention performance, and youth outcomes should be distinguished. They represent different stages and constructs. A result for one would not automatically establish a result for the others, and the registry’s broader aims do not replace outcome-specific evidence.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

A central limitation of the registry record for statistical interpretation is that it does not report numerical primary-outcome results. There are no group means, standard deviations, treatment contrasts, confidence intervals, or primary-comparison test results in the record available for this analysis. The direction, size, and precision of the observed result therefore cannot be assessed.

The primary outcome is scheduled at baseline, mid-point (1 year), and posttest (2 years), but the record does not specify the primary time-point contrast or the model used to analyze repeated measurements. It does not report outcome availability by time, the extent of dropout, or methods for handling missing measurements. Although the outcome is labeled intent to treat and the population description says all the data was used despite dropouts, the analysis details remain unclear.

The record identifies randomized, parallel allocation and no masking, but does not report the allocation procedure in detail or the statistical handling of coalition-level assignment. The intervention description in the brief summary is truncated, and the control condition is not described in detail. These omissions limit assessment of intervention delivery and comparison conditions.

The registry lists multiple outcomes and analyses, without reporting a multiplicity strategy or detailed statistical plan. It also does not report numerical results for the broader prevention-performance and youth-outcome aims. These are limits of what can be interpreted from the registry record, not evidence that the trial did not collect or analyze those data.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Enhancing Prevention Capacity With Developmental Assets and Getting to Outcomes — NCT00780338.
• Registry record last updated 2015-06-01; status last verified 2015-05.
• Results first posted 2015-05-07.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT00780338 is a completed Phase 2 randomized, parallel-group study with no masking, sponsored by RAND. The registry lists enrollment of 376, a start date of 2008-06, and a primary completion date of 2013-01. The study concerns Assets Getting To Outcomes and community-based prevention coalitions in Maine.

The primary outcome is practitioner GTO efficacy, measured through a Coalition Survey and expressed as a percentage of the highest possible score. The intended assessment times are baseline, mid-point (1 year), and posttest (2 years). The record labels the primary analysis intent to treat and describes all the data as used despite dropouts.

Numerical primary and secondary outcome results, detailed missing-data methods, and the statistical analysis plan are not reported in the registry record. The safety summary records zero affected for serious and other adverse events in both listed groups, while deaths are not reported.